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Senior Manager, Statistical Programming Lead

2 months ago

San Francisco, California, United States Meet Recruitment Limited Full time

Job Title: Senior Manager, Statistical Programming

Job Summary:

Meet Recruitment Limited is seeking an experienced Senior Manager of Statistical Programming to join our team. As a key member of our clinical stage biopharma client, you will be responsible for hands-on programming for clinical studies, including exploratory analyses, regulatory responses, and defense activities.

Key Responsibilities:

  • Conduct programming for individual and pooled analyses, ensuring high-quality results and compliance with industry standards.
  • Develop and validate statistical programs, leveraging expertise in programming and statistical methods.
  • Prepare specifications and datasets according to established standards, ensuring accuracy and consistency.
  • Contribute to study-related documents, including protocols, reports, and regulatory submissions.
  • Identify and address data issues, collaborating with cross-functional teams to resolve complex problems.
  • Maintain expertise in programming and statistical methods, staying up-to-date with industry developments and best practices.
  • Respond to regulatory queries, providing clear and concise explanations of statistical results.
  • Support the statistical computing environment, ensuring efficient and effective data management.
  • Work with external vendors and oversee outsourced tasks, ensuring seamless collaboration and high-quality deliverables.
  • Communicate effectively across functions, including project managers, data managers, and regulatory affairs teams.

Requirements:

  • Advanced degree in Statistics or a related field, with relevant experience, or a Bachelor's degree with significant experience in statistical programming.
  • Proficiency in SAS and visualization tools, with experience in data standards and validation tools.
  • Understanding of clinical protocols and data management, including safety and efficacy analyses.
  • Strong communication and teamwork skills, with the ability to manage projects and adapt to changes.